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510(k) Data Aggregation
(240 days)
GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly pure beta tricalcium phosphate granules for use in the repair of bony defects.
This document is a 510(k) Premarket Notification for a medical device called GranOS™ - beta tricalcium phosphate synthetic bone granules. It establishes substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic or prognostic performance. The information provided does not describe a clinical study in the typical sense of measuring diagnostic accuracy or treatment effectiveness with human subjects.
Therefore, the requested information elements related to diagnostic performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for a diagnostic AI device are not applicable to this document. This document focuses on the technical and safety characteristics for regulatory approval as a bone void filler.
However, I can extract the relevant information from the document regarding the device's technical characteristics and how it meets regulatory standards for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like bone void fillers, "acceptance criteria" are typically defined by recognized standards and comparison to predicate devices, focusing on material properties, biocompatibility, and intended use. The performance is then demonstrated through non-clinical testing to meet these standards and show equivalence to predicates.
| Acceptance Criteria / Characteristic Type | Specific Criteria / Predicate Values | Reported Device Performance (GranOS™) |
|---|---|---|
| Chemical Composition | Beta tricalcium phosphate Ca3(PO4)2 meeting ASTM F 1088-04a (2010) | Beta tricalcium phosphate Ca3(PO4)2 meeting ASTM F 1088-04a (2010), same as predicates |
| Patient Population | Individuals with bony defects resulting from surgery or trauma | Individuals with bony defects resulting from surgery or trauma, same as predicates |
| Anatomical Locations | Bony voids/gaps in extremities, posterolateral spine, and pelvis | To be packed into irregular shaped bony voids of the skeletal system (extremities, spine, pelvis), same as predicates |
| Physical Structure | Interconnected porosity (most predicates) / Trabecular structure (one predicate) | Interconnected porosity |
| Porosity | Approximately 70% (two predicates) / 60-70% (one predicate) / 90% (one predicate) | Approximately 70% |
| Pore Size | Micropores <1 - 700μm (one predicate) / >0-<80 μm (one predicate) / 1-1000 μm | Micropores <1 - 700μm |
| Osteoconductivity | Osteoconductive | Osteoconductive |
| Sterility | Sterilised by Gamma Radiation, SAL of 1 x 10^-6 | Sterilised by Gamma Radiation, single use only, Sterility Assurance Level (SAL) of 1 x 10^-6, same as predicates |
| Biocompatibility | Established (for all predicates) | Established |
| Presentation (Granule Sizes) | Varies among predicates (e.g., 250-500μm, 1-2.8mm, 2-4mm, 500-1000μm, 1-4mm morsels) | Granule Sizes: 250-500μm, 1-2.8mm, 2-4mm (matches one predicate exactly, similar ranges to others) |
| Critical Specifications | Chemistry, crystallinity, physical form, porosity, dissolution/solubility | GranOS™ demonstrated to have the same critical specifications as the predicate device through non-clinical performance tests. |
| Regulatory Guidance Adherence | Meet "The Class II Special Controls Guidance: Document Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA" | Key requirements and recommendations met within the specified Class II Special Controls Guidance. |
| Contraindications, Instructions, Warnings, Precautions, Adverse Reactions | Same as predicate devices to avoid new questions regarding safety and effectiveness | GranOS™ has the same Contraindications, Instructions, Warnings, Precautions, and possible adverse reactions/complications when directly compared to the predicate devices. |
Study Proving Device Meets Acceptance Criteria:
The document describes non-clinical testing as the primary study type to demonstrate that GranOS™ meets acceptance criteria and is substantially equivalent to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
This is not applicable as this is a non-clinical submission. The "test set" here refers to the physical samples of the GranOS™ material itself that underwent laboratory testing. The document does not specify a numerical sample size for these material tests, nor does it refer to data provenance in terms of country of origin or retrospective/prospective studies. Such details would typically be found in the full test reports, not summarized in the 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This is not applicable. The "ground truth" for material properties is established through validated laboratory testing methods per recognized standards (e.g., ASTM F1088-04a). Expert review would be part of the quality system and regulatory submission process, but not in the sense of adjudicating diagnostic findings.
4. Adjudication Method for the Test Set:
Not applicable for non-clinical material testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a biomaterial, not a diagnostic imaging AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a biomaterial, so there is no algorithm or AI component.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established by technical specifications and recognized performance standards (e.g., ASTM F1088-04a for beta tricalcium phosphate for Surgical Implantation) and direct comparison to legally marketed predicate devices in terms of material characteristics, intended use, and safety profile.
8. Sample Size for the Training Set:
Not applicable. There is no AI or algorithm involved, and thus no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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